Delirium - PostoperativeNCT06772129
The Effect of Aromatherapy on Delirium in Critically Elderly Patients Undergoing Fracture Surgery
A study testing Aromatherapy in people with Delirium - Postoperative, run by Senay Gokdemir.
Trial summary
The aim of this quasi-experimental study was to examine the effect of lavender aromatherapy on delirium in patients who underwent fracture surgery, were in intensive care, and were over 60 years old. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium - Postoperative
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having had surgery for a fracture and being treated in the ICU
- Being 60 years of age or older
- Having a first measured Nu-Desc score of less than 2
- Having a Glasgow coma scale score of \>13
- Being able to speak and understand Turkish
Who cannot join
- Having trouble smelling
- Being intubated
- Having asthma, COPD or any respiratory disorder
- Having been previously diagnosed with delirium
- Having other cognitive disorders such as Alzheimer\'s or dementia
- The patient needs to be physically restrained.
- Having multiple fractures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this quasi-experimental study was to examine the effect of lavender aromatherapy on delirium in patients who underwent fracture surgery, were in intensive care, and were over 60 years old.
The main question of the study was, does lavender aromatherapy affect delirium scale scores? In order to examine the effect of lavender oil on delirium, the researcher will provide routine care to one group and apply aromatherapy to the other group.
Both groups will be evaluated by the researcher at eight-hour intervals with the Nu-DESC delirium screening scale and the results will be compared.
Read the detailed description
The American Nurses Association has defined delirium as "acute, serious, and often preventable conditions that are usually accompanied by confusion, dehydration, or attacks on some system followed by confusion and a distressing course of life". The incidence of delirium in the postoperative period is quite high and delirium has been associated with longer intensive care unit or hospital stays, higher hospital costs, and increased mortality. Delirium is especially risky in elderly and critically ill patients. Although postoperative delirium is tried to be treated using medication, nonpharmacological prevention methods are considered the most important part of the treatment. One of these methods is aromatherapy and has recently been widely used in nursing research. The smell of waste caused by patients' sweating, urinary and fecal incontinence, bleeding, and antiseptics such as povidone iodide, chlorhexidine, alcohol, and other drugs used during the treatment process creates a hospital-specific odor. Hospital odor is also associated with poor perception of treatment and care. It is thought that it would be beneficial to put an aromatic essential oil such as lavender oil in the environment. The positive effects of aromatherapy with lavender oil on anxiety, stress, pain, sleep quality, nausea and vomiting, as well as its sedative, emotionally calming, antiseptic, analgesic and antispasmodic properties have been demonstrated by studies. Essential oils are considered safe to use because they have minimal side effects. Postoperative delirium is a common complication following hip fracture surgery in the elderly. It has been observed that studies on the development of delirium in the intensive care unit were mostly conducted with patients who underwent cardiovascular surgery. This study will be carried out to determine how lavender oil aromatherapy left in the environment to prevent delirium, which can have serious consequences in the elderly with postoperative fractures, affects delirium scores.
- Conditions
- Delirium - Postoperative
- Being tested
- Aromatherapy
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Studies have been reviewed and no lavender aromatherapy has been found to be used for delirium.
| Study group | Role | What they receive |
|---|---|---|
| aromatherapy group | Active comparator | The intervention to be performed in addition to routine care is to apply 0.3ml lavender oil to the aromatherapy necklace and leave it in an area 30 cm away from the patient's bed. Receives: Other: Aromatherapy |
| control group | No intervention | While normal care and treatment in intensive care will continue to be applied to this group, necessary measurements will be taken and recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
There is a difference between the delirium scores of aromatherapy and control elderly intensive care patients who have undergone fracture surgery.
The Nu-DESC scale will be used to diagnose delirium. The Nu-DESC is an observational five-item scale that can be completed quickly. Symptoms are graded from 0 to 2 based on the presence and intensity of each symptom. Delirium may be considered if the patient's total score is 2 or higher.
Measured: The Nu-DESC score will be measured and recorded at 8-hour intervals for 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Senay Gokdemir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Senay Gokdemir, Necmettin Erbakan University
- Investigators
- Saide Faydalı, Associate Professor, Study director, Necmettin Erbakan University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772129
- Sponsor's protocol ID
- SGokdemir
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mosk CA, Mus M, Vroemen JP, van der Ploeg T, Vos DI, Elmans LH, van der Laan L. Dementia and delirium, the outcomes in elderly hip fracture patients. Clin Interv Aging. 2017 Mar 10;12:421-430. doi: 10.2147/CIA.S115945. eCollection 2017.
PubMed 28331300French J, Weber T, Ge B, Litofsky NS. Postoperative Delirium in Patients After Brain Tumor Surgery. World Neurosurg. 2021 Nov;155:e472-e479. doi: 10.1016/j.wneu.2021.08.089. Epub 2021 Aug 26.
PubMed 34455093Askarkafi F, Rayyani M, Dehghan M. The Effect of Massage With and Without Aromatic Oil on Delirium After Open-Heart Surgery: A Randomized Controlled Trial. J Chiropr Med. 2020 Mar;19(1):49-57. doi: 10.1016/j.jcm.2019.08.001. Epub 2020 Sep 3.
PubMed 33192191
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy on Delirium in Critically Elderly Patients Undergoing Fracture Surgery
- ClinicalTrials.gov ID
- NCT06772129
- Acronym / sponsor ID
- SGokdemir
- Conditions
- Delirium - Postoperative
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Senay GokdemirUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this quasi-experimental study was to examine the effect of lavender aromatherapy on delirium in patients who underwent fracture surgery, were in intensive care, and were over 60 years old.
The main question of the study was, does lavender aromatherapy affect delirium scale scores? In order to examine the effect of lavender oil on delirium, the researcher will provide routine care to one group and apply aromatherapy to the other group.
Both groups will be evaluated by the researcher at eight-hour intervals with the Nu-DESC delirium screening scale and the results will be compared.
Detailed description
The American Nurses Association has defined delirium as "acute, serious, and often preventable conditions that are usually accompanied by confusion, dehydration, or attacks on some system followed by confusion and a distressing course of life". The incidence of delirium in the postoperative period is quite high and delirium has been associated with longer intensive care unit or hospital stays, higher hospital costs, and increased mortality. Delirium is especially risky in elderly and critically ill patients. Although postoperative delirium is tried to be treated using medication, nonpharmacological prevention methods are considered the most important part of the treatment. One of these methods is aromatherapy and has recently been widely used in nursing research. The smell of waste caused by patients' sweating, urinary and fecal incontinence, bleeding, and antiseptics such as povidone iodide, chlorhexidine, alcohol, and other drugs used during the treatment process creates a hospital-specific odor. Hospital odor is also associated with poor perception of treatment and care. It is thought that it would be beneficial to put an aromatic essential oil such as lavender oil in the environment. The positive effects of aromatherapy with lavender oil on anxiety, stress, pain, sleep quality, nausea and vomiting, as well as its sedative, emotionally calming, antiseptic, analgesic and antispasmodic properties have been demonstrated by studies. Essential oils are considered safe to use because they have minimal side effects. Postoperative delirium is a common complication following hip fracture surgery in the elderly. It has been observed that studies on the development of delirium in the intensive care unit were mostly conducted with patients who underwent cardiovascular surgery. This study will be carried out to determine how lavender oil aromatherapy left in the environment to prevent delirium, which can have serious consequences in the elderly with postoperative fractures, affects delirium scores.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aromatherapy group | Active comparator | Other: AromatherapyThe intervention to be performed in addition to routine care is to apply 0.3ml lavender oil to the aromatherapy necklace and leave it in an area 30 cm away from the patient's bed. |
| control group | No intervention | –While normal care and treatment in intensive care will continue to be applied to this group, necessary measurements will be taken and recorded. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having had surgery for a fracture and being treated in the ICU
- Being 60 years of age or older
- Having a first measured Nu-Desc score of less than 2
- Having a Glasgow coma scale score of \>13
- Being able to speak and understand Turkish
Key exclusion criteria (7 listed)
- Having trouble smelling
- Being intubated
- Having asthma, COPD or any respiratory disorder
- Having been previously diagnosed with delirium
- Having other cognitive disorders such as Alzheimer\'s or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapyStudies have been reviewed and no lavender aromatherapy has been found to be used for delirium. | Other | aromatherapy group |
Primary outcome
There is a difference between the delirium scores of aromatherapy and control elderly intensive care patients who have undergone fracture surgery.
Time frame: The Nu-DESC score will be measured and recorded at 8-hour intervals for 24 hours after surgery.
The Nu-DESC scale will be used to diagnose delirium. The Nu-DESC is an observational five-item scale that can be completed quickly. Symptoms are graded from 0 to 2 based on the presence and intensity of each symptom. Delirium may be considered if the patient's total score is 2 or higher.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Results publication: PubMed 28331300Mosk CA, Mus M, Vroemen JP, van der Ploeg T, Vos DI, Elmans LH, van der Laan L. Dementia and delirium, the outcomes in elderly hip fracture patients. Clin Interv Aging. 2017 Mar 10;12:421-430. doi: 10.2147/CIA.S115945. eCollection 2017.
- Results publication: PubMed 34455093French J, Weber T, Ge B, Litofsky NS. Postoperative Delirium in Patients After Brain Tumor Surgery. World Neurosurg. 2021 Nov;155:e472-e479. doi: 10.1016/j.wneu.2021.08.089. Epub 2021 Aug 26.
- Results publication: PubMed 33192191Askarkafi F, Rayyani M, Dehghan M. The Effect of Massage With and Without Aromatic Oil on Delirium After Open-Heart Surgery: A Randomized Controlled Trial. J Chiropr Med. 2020 Mar;19(1):49-57. doi: 10.1016/j.jcm.2019.08.001. Epub 2020 Sep 3.
- American Delirium SocietyLink provided by the sponsor.
- American Nursing AssociationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saide Faydalı, Associate Professor study director
Necmettin Erbakan University, Faculty of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Delirium - Postoperative, run by Senay Gokdemir.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact şenay Gökdemir, specialist nurse (+905373498551, gokdemirsenay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
There is a difference between the delirium scores of aromatherapy and control elderly intensive care patients who have undergone fracture surgery. (time frame: The Nu-DESC score will be measured and recorded at 8-hour intervals for 24 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06772129, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.